Blended-care CounsellingSTEPS@SCHOOLNCT06390384
Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
A study testing blinded-care counselling, App STEPS and digital and mental literacy training in people with Blended-care Counselling and Digital and Mental Literacy Training, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The objectives of this two-arm phase-IIa randomized, controlled study are: to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Blended-care Counselling, Digital and Mental Literacy Training, App STEPS
- What is being tested?
- blinded-care counselling, App STEPS and digital and mental literacy training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents of both genders (w : m = 1 : 1) aged from 10 to 14 years
- Psychiatric symptoms characterized using SDQ-25 with the cutoff > 17
- Regular school attendence
Who cannot join
- IQ <80, ongoing psychiatric or psychotherapeutic treatment with regular appointments (at least once a month).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Sotnikova, Dr. contact
Germany1 site
Clinic of Child and Adolescent Psychiatry, RWTH Aachen University
Aachen, North Rhine-Westphalia, 52074
Michael Siniatchkin, Prof. Dr.
Anna Sotnikova, Dr.
About this study
The objectives of this two-arm phase-IIa randomized, controlled study are:
- to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents.
- to improve the well-being and level of participation in adolescents at risk for psychiatric disorders.
- to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden.
- to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers.
- to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists).
- to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.
Read the detailed description
The objectives of this two-arm phase-IIa randomized, controlled study are:
- to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents.
- to improve the well-being and level of participation in adolescents at risk for psychiatric disorders.
- to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden.
- to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers.
- to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists).
- to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.
The STEPS@SCHOOL clinical study is a two-arm parallel group phase-IIa randomized, non-blinded, controlled study with four measurement points (T1: confirming the risk status/checking inclusion criteria/informed consent; T2: baseline assessment and randomization prior to start of intervention; T3: post intervention assessment; T4: three months follow-up). The study will prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (first arm) is superior to a teacher-guided digital preventive platform with stand-alone digital applications (second arm, described as treatment as usual) concerning the reduction of psychiatric burden in adolescents. To prove this objective, a comparison between two groups (treatment of approval vs. treatment as usual) is necessary.
The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school; 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents; 3) blinded-care use of the mobile treatment system STEPS®.
Control condition (Treatment as Usual) includes the implementation of the digital and mental literacy training, however, no weekly counselling by the team of the clinic and no blinded-care use of the mobile treatment system STEPS®.
- Being tested
- blinded-care counselling, App STEPS, digital and mental literacy training
- Keywords
- eMental health, digital health, blended care treatment, students at risk in schools, psychiatric disorders, adolescents
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blinded-care counsellingOther
The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents.
The counselling will be provided by experienced psychologists as employers of the Clinic of Child and Adolescent Psychiatry, RWTH Aachen University, the counselling will be supervised by the leading psychologist of the clinic. The counselling will include psychoeducative elements about psychological and psychosocial problems, behavioral interventions from cognitive-behavioral therapy, psychological techniques for better coping with stress, different therapeutic tasks such as fear exposure, activation exercises e.c. The students will be instructed to use the mobile treatment system STEPS in order to continue therapy at home.
App STEPSOther
The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 3) blinded-care use of the mobile treatment system STEPS®.
This is transdiagnostic digital treatment system which consists of a students front-end as an App and a therapist front-end as an online platform. The App and the platform are connected to each other. In such a way, an effective data transter (for example, symptom evaluation by the student and tasks and requests by the therapist), direct communication between a student and a therapist, as well as registration of emergency situation, are possible.
digital and mental literacy trainingOther
The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®.
The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school.
This training program (4 weeks, 8 session a 2 lesson units, 2 sessions a week) includes information about rules and functions by using mobile applications, safety aspects of personal data, risks associated with data sharing, sexing and cybergrooming, managing social media, handling with fake news, influence of social media on mental health, forms of digital violence and strategies to cope with them.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | blinded-care counselling + App STEPS + digital and mental literacy training Receives: Other: blinded-care counselling; Other: App STEPS; Other: digital and mental literacy training |
| TAU group (Treatment as Usual) | No intervention | digital and mental literacy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student's well-being and level of participation
Student's well-being and level of participation measured by KIDSCREEN-27.
Measured: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Secondary outcomes (3)
Reduction of psychiatric burden
Reduction of psychiatric burden as measured by SDQ-25, children/parent/teacher ) as well as SYMPTOM MONITORING as a daily individual symptom estimation on the likert scale in the Appversions.
Measured: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Reduction of children's global impairment
Reduction of children's global impairment will be assessed by the the German version of the Chil-dren Global Assessment Scale.
Measured: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Feasibility measures
Feasibility measures: number of students completed the programme, number of counselling ses-sions a student/parent, number of days/hours with STEPS support e.c..
Measured: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Blended-care CounsellingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school; 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents; 3) blinded-care use of the mobile treatment system STEPS®. Control condition (Treatment as Usual) includes the implementation of the digital and mental literacy training, however, no weekly counselling by the team of the clinic and no blinded-care use of the mobile treatment system STEPS®.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390384
- Sponsor's protocol ID
- STEPS@SCHOOL
- Acronym
- STEPS@SCHOOL
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dallinger VC, Krishnamoorthy G, du Plessis C, Pillai-Sasidharan A, Ayres A, Waters L, Groom Y, Alston O, Anderson L, Burton L. Utilisation of Digital Applications for Personal Recovery Amongst Youth with Mental Health Concerns. Int J Environ Res Public Health. 2022 Dec 14;19(24):16818. doi: 10.3390/ijerph192416818.
PubMed 36554700Damian AJ, Gallo JJ, Mendelson T. Barriers and facilitators for access to mental health services by traumatized youth. Child Youth Serv Rev. 2018 Jan;85:273-278. doi: 10.1016/j.childyouth.2018.01.003. Epub 2018 Jan 7.
PubMed 29795708Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332.
PubMed 28546138Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health. 2010 Mar;37(1-2):61-70. doi: 10.1007/s10488-010-0294-z.
PubMed 20232133Iskra W, Deane FP, Wahlin T, Davis EL. Parental perceptions of barriers to mental health services for young people. Early Interv Psychiatry. 2018 Apr;12(2):125-134. doi: 10.1111/eip.12281. Epub 2015 Oct 20.
PubMed 26487568Punukollu M, Marques M. Use of mobile apps and technologies in child and adolescent mental health: a systematic review. Evid Based Ment Health. 2019 Nov;22(4):161-166. doi: 10.1136/ebmental-2019-300093. Epub 2019 Jul 29.
PubMed 31358537
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric Burden in the School Environment.
- ClinicalTrials.gov ID
- NCT06390384
- Acronym / sponsor ID
- STEPS@SCHOOL / STEPS@SCHOOL
- Keywords
- eMental health, digital health, blended care treatment, students at risk in schools, psychiatric disorders, adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this two-arm phase-IIa randomized, controlled study are:
- to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents.
- to improve the well-being and level of participation in adolescents at risk for psychiatric disorders.
- to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden.
- to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers.
- to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists).
- to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.
Detailed description
The objectives of this two-arm phase-IIa randomized, controlled study are:
- to prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (blinded care approach) and a training of digital and mental health literacy is superior to a teacher-guided training of digital and mental health literacy only (treatment as usual) concerning the reduction of psychiatric burden in adolescents.
- to improve the well-being and level of participation in adolescents at risk for psychiatric disorders.
- to reduce the expression of psychiatric symptoms in adolescents with enhanced psychiatric burden.
- to test whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support is well accepted by students, their parents, and teachers.
- to identify individual factors predicting the improvement of well-being and level of participation in adolescents as well as the acceptance of the prevention program in all subjects involved (students, parents, teachers, psychologists).
- to investigate whether the clinic-guided personal counseling with a therapy-assistive digital support causes reduction of primary and secondary costs in the psychosocial support system and represents an economic advantage.
The STEPS@SCHOOL clinical study is a two-arm parallel group phase-IIa randomized, non-blinded, controlled study with four measurement points (T1: confirming the risk status/checking inclusion criteria/informed consent; T2: baseline assessment and randomization prior to start of intervention; T3: post intervention assessment; T4: three months follow-up). The study will prove whether the combination of a clinic-guided personal counseling with a therapy-assistive digital support (first arm) is superior to a teacher-guided digital preventive platform with stand-alone digital applications (second arm, described as treatment as usual) concerning the reduction of psychiatric burden in adolescents. To prove this objective, a comparison between two groups (treatment of approval vs. treatment as usual) is necessary.
The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school; 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents; 3) blinded-care use of the mobile treatment system STEPS®.
Control condition (Treatment as Usual) includes the implementation of the digital and mental literacy training, however, no weekly counselling by the team of the clinic and no blinded-care use of the mobile treatment system STEPS®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school; 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents; 3) blinded-care use of the mobile treatment system STEPS®. Control condition (Treatment as Usual) includes the implementation of the digital and mental literacy training, however, no weekly counselling by the team of the clinic and no blinded-care use of the mobile treatment system STEPS®.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: blinded-care counselling, Other: App STEPS, Other: digital and mental literacy trainingblinded-care counselling + App STEPS + digital and mental literacy training |
| TAU group (Treatment as Usual) | No intervention | –digital and mental literacy training |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children and adolescents of both genders (w : m = 1 : 1) aged from 10 to 14 years
- Psychiatric symptoms characterized using SDQ-25 with the cutoff > 17
- Regular school attendence
Key exclusion criteria (1 listed)
- IQ <80, ongoing psychiatric or psychotherapeutic treatment with regular appointments (at least once a month).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blinded-care counsellingThe intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 2) weekly counselling over 6 weeks via videoconference for adolescents and their parents. The counselling will be provided by experienced psychologists as employers of the Clinic of Child and Adolescent Psychiatry, RWTH Aachen University, the counselling will be supervised by the leading psychologist of the clinic. The counselling will include psychoeducative elements about psychological and psychosocial problems, behavioral interventions from cognitive-behavioral therapy, psychological techniques for better coping with stress, different therapeutic tasks such as fear exposure, activation exercises e.c. The students will be instructed to use the mobile treatment system STEPS in order to continue therapy at home. | Other | Intervention group |
| App STEPSThe intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 3) blinded-care use of the mobile treatment system STEPS®. This is transdiagnostic digital treatment system which consists of a students front-end as an App and a therapist front-end as an online platform. The App and the platform are connected to each other. In such a way, an effective data transter (for example, symptom evaluation by the student and tasks and requests by the therapist), direct communication between a student and a therapist, as well as registration of emergency situation, are possible. | Other | Intervention group |
| digital and mental literacy trainingThe intervention is a implementation of a weekly psychological counseling for psychiatric problems via videoconference combined with an additionally digital support using a well-established mobile treatment system STEPS®. The intervention will include: 1) digital and mental literacy training for children, parents and teachers in the school. This training program (4 weeks, 8 session a 2 lesson units, 2 sessions a week) includes information about rules and functions by using mobile applications, safety aspects of personal data, risks associated with data sharing, sexing and cybergrooming, managing social media, handling with fake news, influence of social media on mental health, forms of digital violence and strategies to cope with them. | Other | Intervention group |
Primary outcome
Student's well-being and level of participation
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Student's well-being and level of participation measured by KIDSCREEN-27.
3 secondary outcomes
Reduction of psychiatric burden
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Reduction of children's global impairment
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Feasibility measures
Time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 36554700Dallinger VC, Krishnamoorthy G, du Plessis C, Pillai-Sasidharan A, Ayres A, Waters L, Groom Y, Alston O, Anderson L, Burton L. Utilisation of Digital Applications for Personal Recovery Amongst Youth with Mental Health Concerns. Int J Environ Res Public Health. 2022 Dec 14;19(24):16818. doi: 10.3390/ijerph192416818.
- Background: PubMed 29795708Damian AJ, Gallo JJ, Mendelson T. Barriers and facilitators for access to mental health services by traumatized youth. Child Youth Serv Rev. 2018 Jan;85:273-278. doi: 10.1016/j.childyouth.2018.01.003. Epub 2018 Jan 7.
- Background: PubMed 28546138Grist R, Porter J, Stallard P. Mental Health Mobile Apps for Preadolescents and Adolescents: A Systematic Review. J Med Internet Res. 2017 May 25;19(5):e176. doi: 10.2196/jmir.7332.
- Background: PubMed 20232133Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health. 2010 Mar;37(1-2):61-70. doi: 10.1007/s10488-010-0294-z.
- Background: PubMed 26487568Iskra W, Deane FP, Wahlin T, Davis EL. Parental perceptions of barriers to mental health services for young people. Early Interv Psychiatry. 2018 Apr;12(2):125-134. doi: 10.1111/eip.12281. Epub 2015 Oct 20.
- Background: PubMed 31358537Punukollu M, Marques M. Use of mobile apps and technologies in child and adolescent mental health: a systematic review. Evid Based Ment Health. 2019 Nov;22(4):161-166. doi: 10.1136/ebmental-2019-300093. Epub 2019 Jul 29.
- Individual participant dataSharing planned: No
Related trials for Blended-care Counselling
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Sotnikova, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blinded-care counselling, App STEPS and digital and mental literacy training in people with Blended-care Counselling and Digital and Mental Literacy Training, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Siniatchkin, Prof. Dr. (+49 241 80-89362, msiniatchkin@akaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student's well-being and level of participation (time frame: T2 (baseline) vs. T3 (post intervention assessment within one week); T2 (baseline) vs. T4 (3 months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390384, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.